Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.

Michelle A Van Name, Lauren G Kanapka, Linda A DiMeglio, Kellee M Miller, Anastasia Albanese-O'Neill, Persis Commissariat, Sarah D Corathers, Kara R Harrington, Marisa E Hilliard, Barbara J Anderson, Jennifer C Kelley, Lori M Laffel, Sarah A MacLeish, Brandon M Nathan, William V Tamborlane, R Paul Wadwa, Steven M Willi, Kristen M Williams, Kupper A Wintergerst, Stephanie Woerner, Jenise C Wong, Daniel J DeSalvo

Journal: Journal of diabetes science and technology 2023;17(4):976-987

PMID: 35343269

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Plain Language Summary

Achieving optimal glycaemic outcomes in young children with type 1 diabetes (T1D) is challenging. Hence, young children with T1D spend little time in optimal glycaemic range and are at risk for both severe hypoglycaemia and hyperglycaemia. The aim of this study was to examine the durability of continuous glucose monitoring (CGM) coupled with a family behavioural intervention (FBI) to improve glycemia. This study was a 26-week randomised clinical trial which enrolled 143 youth aged two to less than eight years. Results showed that over the 12-month period, young children with T1D using newer CGM technology sustained reductions in hypoglycaemia. Unlike prior studies, they persistently wore CGM. However, pervasive hyperglycaemia remained unmitigated. Authors concluded that their findings highlight the benefits of CGM in reducing hypoglycemia risk, but they also underscore the ongoing challenge of managing hyperglycemia in this population.

Abstract

OBJECTIVES

Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia.

STUDY DESIGN

This one-year study included an initial 26-week randomized controlled trial of CGM with FBI () and CGM alone () compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI () and both original CGM groups continued this technology.

RESULTS

Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, -values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%).

CONCLUSION

Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.

Address: Yale School of Medicine, New Haven, CT, USA.; Jaeb Center for Health Research, Tampa, FL, USA.; Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.; Department of Pediatrics, University of Florida, Gainesville, FL, USA.; Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.; Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.; Vanderbilt University Medical Center, Nashville, TN, USA.; Rainbow Babies and Children's Hospital, Cleveland, OH, USA.; University of Minnesota, Minneapolis, MN, USA.; Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.; Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.; Naomi Berrie Diabetes Center, Columbia University, New York, NY, USA.; Wendy Novak Diabetes Center, University of Louisville, Norton Children's Hospital, Louisville, KY, USA.; Madison Clinic for Pediatric Diabetes, University of California San Francisco, San Francisco, CA, USA.

DOI: 10.1177/19322968221084667